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[68 Ga]-DOTANOC PET/CT in GEP-NETs (GEP-NOC)

Primary Purpose

Gastroenteropancreatic Neuroendocrine Tumors

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
[68Ga]-DOTANOC PET/CT
Sponsored by
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Gastroenteropancreatic Neuroendocrine Tumors

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age> 18 years, with affiliation to the Social Security.
  2. Written consent of the patient.
  3. Patients with any of the following 5 situations:

    • GEPs without metastasis.
    • GEPs with unilateral liver metastases candidates to unilateral hepatectomy.
    • GEPs with unknown primary tumor.
    • GEPS with livers metastases candidates to liver transplantation.
    • Metastatic GEPs with grade 1 or 2 tumour and negative SRS.
  4. Reference imaging within the last 3 months : multiphasic total body CT scan, liver MRI and SRS (SPECT/CT).

Exclusion Criteria:

  1. minor subject.
  2. Pregnant or breast-feeding.
  3. Absence of therapeutic alternatives in metastatic GEP.
  4. Undifferentiated GEP and/or metastatic GEPs with grade 3 tumours.

Sites / Locations

  • AP-HM

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

patients with gastroenteropancreatic neuroendocrine tumors

Arm Description

Outcomes

Primary Outcome Measures

level of changes (%) between care management before DOTANOC PET and care management after DOTANOC PET

Secondary Outcome Measures

Positive predictive values of DOTANOC PET and standard imaging
negative predictive values of DOTANOC PET and standard imaging
correlation between tumor type and DOTANOC PET results
number of patients for whom PET allowed the detection of lesions not described by standard imaging

Full Information

First Posted
November 9, 2015
Last Updated
October 12, 2022
Sponsor
Assistance Publique Hopitaux De Marseille
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1. Study Identification

Unique Protocol Identification Number
NCT02608203
Brief Title
[68 Ga]-DOTANOC PET/CT in GEP-NETs
Acronym
GEP-NOC
Official Title
Impact of [68 Ga]-DOTANOC PET-CT on the Management of Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs): Prospective, Multicentric Study.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
May 26, 2016 (Actual)
Primary Completion Date
June 24, 2019 (Actual)
Study Completion Date
June 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille

4. Oversight

5. Study Description

Brief Summary
Somatostatin receptors are overexpressed in GEP-NETs and can be visualized in vivo by radiolabeled somatostatin-analogs. During the last decades, conventional scintigraphy using 111In-DTPA-Octreotide (often named somatostatin receptor scintigraphy or SRS) was considered as the gold standard nuclear imaging technique in the evaluation of GEP-NETs. However, SRS may be suboptimal in this clinical setting because of the low intrinsic resolution of the technique and its selectivity for SST2 only. Its overall sensitivity is estimated to 60-70% (per lesion analysis), even when using the most recent SPECT-CT cameras. MRI have also a higher sensitivity than CT and SRS for the detection of liver metastases from GEP-NETs. In recent years, positron emission tomography (PET) imaging, a high resolution and sensitive technology, has gained an increasing role in oncology. It has also been evaluated in GEP-NETs with somatostatin agonists (SSTa) radiolabelled with Gallium-68 [68Ga], a positron emitter with very promising results. Its diagnostic sensitivity is clearly superior to SRS and many European centers have already replaced SRS by [68Ga]-PET-SSTa. Currently, three different [68Ga]-coupled peptides can be used in trials: DOTA-TOC, DOTA-TATE and DOTA-NOC with excellent affinities for SST2 (IC50: 2.5; 0.2 and 1.9 nM, respectively). Sensitivities of DOTA-TOC and DOTA-TATE PET/CT are quite similar. [68Ga]-DOTANOC which also binds to SST5 was recently found to detect significantly more lesions than the SST2-specific radiotracer [68Ga]-DOTATATE in patients with GEP-NETs but this requires further evaluation. It is therefore important to determine the interest of [68Ga]-DOTANOC combined with the standard diagnosis strategy in GEP-NETs and evaluate medicoeconomic impact of adding [68Ga]-DOTANOC in the work-up of patients. The investigators hypothesis is that [68Ga]-DOTANOC will modify the management in at least 20% of patients in a more adapted way according to the 2012 ENETS guidelines in comparison to the decision based on the standard imaging work up (multiphasic WB CT, liver MRI and SRS). 110 patients will be included prospectively in 5 different French experienced centers (Marseille, Bordeaux, Toulouse, Paris, Clermond-Ferrand).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroenteropancreatic Neuroendocrine Tumors

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
patients with gastroenteropancreatic neuroendocrine tumors
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
[68Ga]-DOTANOC PET/CT
Primary Outcome Measure Information:
Title
level of changes (%) between care management before DOTANOC PET and care management after DOTANOC PET
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Positive predictive values of DOTANOC PET and standard imaging
Time Frame
1 year
Title
negative predictive values of DOTANOC PET and standard imaging
Time Frame
1 year
Title
correlation between tumor type and DOTANOC PET results
Time Frame
1 year
Title
number of patients for whom PET allowed the detection of lesions not described by standard imaging
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age> 18 years, with affiliation to the Social Security. Written consent of the patient. Patients with any of the following 5 situations: GEPs without metastasis. GEPs with unilateral liver metastases candidates to unilateral hepatectomy. GEPs with unknown primary tumor. GEPS with livers metastases candidates to liver transplantation. Metastatic GEPs with grade 1 or 2 tumour and negative SRS. Reference imaging within the last 3 months : multiphasic total body CT scan, liver MRI and SRS (SPECT/CT). Exclusion Criteria: minor subject. Pregnant or breast-feeding. Absence of therapeutic alternatives in metastatic GEP. Undifferentiated GEP and/or metastatic GEPs with grade 3 tumours.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Urielle Desalbres
Organizational Affiliation
AP-HM
Official's Role
Study Director
Facility Information:
Facility Name
AP-HM
City
Marseille
Country
France

12. IPD Sharing Statement

Learn more about this trial

[68 Ga]-DOTANOC PET/CT in GEP-NETs

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